At a glance
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A Phase 3 Multi-Center, Placebo-Controlled, Double Blind, 3-Armed Parallel Group, Comparative Study of SPM 962 4.5 and 6.75 mg/Day to Investigate Superiority to Placebo in Patients With Restless Legs Syndrome
In Brief
A Phase 3 clinical trial evaluating SPM 962 and Placebo of SPM 962 for Idiopathic Restless Legs Syndrome. Completed, enrolled 284 participants across 8 sites.
Detailed Summary
The objective of this study is to evaluate the clinical efficacy and safety of SPM962 in patients with restless legs syndrome (RLS) with once-daily repeated doses of 4.5mg and 6.75mg during a 13-week dose-titration and maintenance period. This is a multi-center, randomized, placebo-controlled, double-blind, 3-armed parallel group comparison study. Efficacy will be determined by investigating the superiority of SPM962 to placebo in terms of the primary efficacy variable, change in International Restless Legs Syndrome Rating Scale (IRLS) total score from baseline to the end of the dose-maintenance period.
Study Details
Timeline
Interventions
once a daily transdermal administration started at 2.25 mg/day to 4.5 mg/day for 13 weeks
once a daily transdermal administration started at 2.25 mg/day to 6.75 mg/day for 13 weeks
once a daily transdermal administration for 13 weeks